Adverse Event (AE): Any undesirable experience associated with the use of a medical product in a patient during a clinical trial.

Amendment (Protocol): A written description of a change to the protocol or to the informed consent document.

Baseline: The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.

Bias:  A point of view or preference which prevents impartial judgment in the way in which a measurement, assessment, procedure, or analysis is carried out or reported.

Blinding (Masking):  A method to reduce bias in clinical trials by preventing participants, investigators, or assessors from knowing which intervention participants receive.

Bioavailability: The extent and rate at which the active drug ingredient is absorbed and becomes available at the site of action.

Case Report Form (CRF): A printed or electronic document used to record protocol-required information on each subject during a clinical trial.

Clinical Trial: A research study in which human volunteers are assigned to interventions to evaluate the effects on health outcomes.

Comparator: A standard treatment or placebo used for comparison in a clinical trial.

Coordinating Centre (CC):  A group organized to coordinate the planning and operational aspects of a multi-centre clinical trial. CCs may also be referred to as Data Coordinating Centres (DCCs) or Data Management Centres (DMCs).

Clinical Research or Study Coordinator (CRC): An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.

Concomitant Medication: Prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention. This information may be collected as a history item as well as during the study. Some studies may collect only those medications that may interact with the study or intervention or that may exclude an individual from participating in a study.

Conflict of Interest: A conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research.
 

Control Group: The group of individuals in a clinical trial assigned to a comparison intervention.

Controlled Clinical Trial: A clinical trial in which at least one group of participants is given a test intervention, while at least one other group concurrently receives a control intervention.

Data Monitoring Committee (DMC): An independent group that reviews data while a clinical trial is in progress to ensure participant safety and study integrity.

Double-blind Study: Neither the participants nor the researchers know which treatment the participants are receiving.

Data Management: The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.

Data Management Plan (DMP): A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described.

Data and Safety Monitoring Board (DSMB): A group of individuals independent of the study investigators that is appointed by the NIA to monitor participant safety, data quality and to assess clinical trial progress.

Data and Safety Monitoring Plan (DSMP): Plan included with the grant application for clinical trials which establishes the overall framework for data and safety monitoring, how adverse events will be reported to the IRB and the NIH and, when appropriate, how the NIH Guidelines and FDA regulations for INDs and IDEs will be satisfied. 

Efficacy: The ability of a drug or intervention to produce the desired beneficial effect in expert-controlled settings.

Eligibility Criteria: List of criteria guiding enrollment of participants into a study. The criteria describe both inclusion criteria and exclusion criteria, 

Enrollment: The number of participants who are recruited and included in a study.

FDA (Food and Drug Administration): The U.S. agency responsible for protecting public health by ensuring the safety and efficacy of drugs, biological products, and medical devices.

First-in-Human (FIH): A type of trial where a drug or therapy is tested in humans for the first time.

Good Clinical Practice (GCP): An international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials.

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).

Human Subject:  A patient or healthy individual who is or becomes a participant in research, either as a recipient of the intervention or as a control.

Hypothesis: A proposed explanation made based on limited evidence, to be tested through research.

Informed Consent: The process of learning key facts about a clinical trial before deciding whether to participate.

Informed Consent Form: A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document.

Institutional Review Board (IRB): A committee that reviews and approves clinical trial protocols to protect participants' rights and welfare.

Independent Ethics Committee (IEC): An independent body constituted of medical, scientific, and non-scientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a Clinical Study and trial.

Intervention: A treatment or action taken to improve health or alter the course of a disease in a study participant.

Investigational New Drug Application (IND): An IND is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. 

Labeling: All labels and other written, printed, or graphic matter upon a drug or any of its containers or wrappers.

Masking/Blinding: A procedure in which the investigator administering the assessments and intervention as well as the participants in a clinical trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the study participant(s) being unaware, and double blinding usually refers to the study participant(s) and any of the following being unaware of the treatment assignment(s): investigator(s), monitor, and data analyst(s).

Manual of Procedures (MOP): A set of procedures describing study conduct. A MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.

Monitoring: Oversight of a clinical trial to ensure compliance with protocol, GCP, and regulatory requirements.

New Drug Application (NDA): An application submitted by the manufacturer of a drug to the FDA, after the clinical trial has been completed, for a license to market the drug for a specified indication

Observational Study Monitoring Board (OSMB): The safety and data monitoring body for observational studies with large or vulnerable populations or risks associated with tests or standard of care.  

Office for Human Research Protection (OHRP): A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.

Open-Label Trial: A clinical trial in which investigators and participants know which intervention is being administered.

Pharmacokinetics: The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.

Phase I: Clinical trials to test a new biomedical intervention in a small population of healthy participants or patients (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects). 

Phase II: Clinical trials to study the biomedical or behavioral intervention in a larger population of patients (several hundred) to evaluate safety and efficacy .

Phase III: Studies to investigate the efficacy of the biomedical or behavioral intervention in larger population of patients (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.

Phase IV: Studies conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

Placebo: A substance with no therapeutic effect used as a control in testing new drugs.

Principal Investigator (PI): The person responsible for the conduct of the clinical trial at a trial site.

Protocol: A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial.

Protocol Amendments: A written description of a change(s) to or formal clarification of a protocol.

Protocol Deviations: Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. 

Protocol Deviations Report: Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.

Prospectively Assigned: A pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.

Quality Assurance (QA): Systematic approach to ensure that the data are generated, documented (recorded), and reported in compliance with the protocol and good clinical practice (GCP) standards.

Quality Control (QC): The internal operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial related activities have been fulfilled (e.g., data and form checks, monitoring by study staff, routine reports, correction actions, etc.).

Randomization: The process of assigning trial participants to treatment groups using an element of chance to reduce bias.

Regulatory Authority: Government agencies responsible for authorizing clinical trials and drug approvals (e.g., CDSCO in India, FDA in the US).

Recruitment Plan: The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.

Retention Plan: The plan that details the methods in which the study will use in order to retain study participation in the clinical trial.

Serious Adverse Event (SAE): An AE that results in death, is life-threatening, requires hospitalization, or causes significant disability/incapacity.

Sponsor: An individual, institution, company, or organization that takes responsibility for initiating and managing a clinical trial.

Subject: A person who participates in a clinical trial, either as a recipient of the intervention or as a control.

Safety Monitoring Plan: A plan that outlines the oversight of a clinical trial.

Screening Log: An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.

Screening Process: A process designed to determine individual’s eligibility for participation in a clinical research study.

Source Document: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical trial.

Standard Operating Procedure (SOPs): Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.

Stopping Rule: Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.

Stratification: Separation of a study cohort into subgroups or strata according to specific characteristics such as age, sex, etc., so that factors which might affect the outcome of the study, can be taken into account.

Trial Master File (TMF): A collection of essential documents for a clinical trial that may be subject to audit or inspection.

Unblinding: The process of revealing the treatment assignments to those who were blinded to it.

Unanticipated Problems (UAPs): Unanticipated problems involving risks to subjects or others, which meet all of the following criteria:

• Unexpected in terms of nature, severity, or frequency;
• Related or possibly related to participation in the research, and;
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Unanticipated Adverse Device Effects (UADEs): Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in a nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application) or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.